Reliable venous access is critical for the safe and effective care of millions of patients every year around the world. In the United States alone roughly 330 million intravascular devices are purchased by hospitals each year, and 60% to 90% of hospitalized patients require an IV catheter during their hospital stay.
Current peripheral catheter securement dressings can be divided into three broad categories: tape/transparent dressings, plastic shields, and adhesive anchors. Recent scientific literature demonstrates that even with the strictest adherence to these current standards, early failure rates are as high as 35-50% when current catheter securement dressing products are utilized. Failure prior to the end of therapy leads to increased trauma and risk of complications as the patient undergoes re-insertion to gain venous access to continue their treatment protocol. The most common complications include dislodgement, phlebitis, and catheter-related bloodstream infections (CRBSI). Reducing the frequency of complications associated with catheter movement can, in turn, reduce the occurrence of needle stick injuries for health care workers and prevent otherwise unnecessary costs for hospital stays.
As a result of the complications associated with IV catheter use, the development of reliable yet cost-effective securement techniques is extremely important. Preliminary studies indicated that a cyanoacrylate adhesive may address this significant problem. In a recent study by Bugden and colleagues peripheral intravenous catheter failure was 10% lower (95% confidence interval—18% to 2%; P=0.02) with skin glue (17%) than standard care (27%), and dislodgement was 7% lower (95% confidence interval—13% to 0%; P=0.04). Wilkinson and Fitz-Henry used a butyl cyanoacrylate to affix epidural catheters and reduced the fall-out rate from 12.3% to 3.8%. The fixation method by cyanoacrylate adhesive was found to be “highly acceptable to the patients” and simple to perform. Klein et al described the use of cyanoacrylate to secure continuous peripheral nerve catheters and, based on their findings, suggested that it could be used in highly mobile locations and even “areas subject to perspiration.” Because of the toughness, durability, and high mechanical strength that a cyanoacrylate adhesive bond provides, Wilkinson, Sheikh, and Jayamaha chose cyanoacrylate for securing central venous catheters, a procedure commonly carried out using sutures; the cyanoacrylate technique reduced patient pain and discomfort from both suturing and removal while also providing a cost benefit. Simonova et al evaluated the use of cyanoacrylate for catheter securement in vitro and found that the adhesives “significantly increased the pull-out force” while being “quick and easy to apply” and preventing bacterial growth both under the adhesive and along the IV tunnel.
In order for adhesive compositions to be utilized in the area of wound/incision closure, a large number of dispensing and packaging systems for cyanoacrylate-based adhesive have been proposed. Example proposals will be discussed seriatim.
U.S. Pat. Nos. 7,306,390 and 6,705,790 issued to Quintero et al. disclose an applicator assembly for dispensing adhesive material having first and second body portions, a frangible ampule container for adhesive, and a breaking member to rupture the container for dispensing the adhesive material.
U.S. Pat. Nos. 6,960,040, 6,494,896, and 6,340,097 to D'Alessio et al. disclose a package assembly suitable for laparoscopic or endoscopic surgery.
U.S. Pat. Nos. 7,128,241, 6,676,322, 6,376,019, 6,322,852, 6,099,807, and 5,928,611 issued to Leung disclose an applicator tip for dispensing cyanoacrylate adhesive stored in a frangible glass ampule container having a porous, absorbent applicator tip that includes a polymerization initiator to accelerate the polymerization of cyanoacrylate adhesive when applied.
U.S. Pat. No. 6,547,467 issued to Quintero discloses a micro-applicator for dispensing and applying cyanoacrylate-based adhesive having a handle portion. A micro-reservoir at the applicator tip holds about 20 microliters or less of adhesive material. The applicator tip may include a spatula, a rolling ball, a grate, a porous material, or a brush.
U.S. Pat. No. 6,779,657 issued to Mainwaring et al. discloses a single-use applicator assembly for applying and dispensing cyanoacrylate monomeric adhesive material comprising a base with at least one sealed container and an applicator tip at least partially disposed in the container such that the tip of the applicator has access to the adhesive material.
U.S. Pat. No. 7,297,217 issued to Dewitt discloses a dispenser for application of a special low viscosity cyanoacrylate adhesive which is used for the manufacture and repair of wooden furniture. The dispenser is provided with a closure member having a metallic pin that penetrates the discharge opening while the closure member is being secured on.
U.S. Pat. No. 4,413,753 issued to Stock discloses a self-draining tip for dispensing cyanoacrylate adhesives that includes a single or segmented, constant-diameter passageway having sharp-edged annular terminations.
U.S. Pat. No. 4,685,591 issued to Schaefer et al. discloses a packaging tube that is suitable for storing and dispensing products containing substantial fractions of cyanoacrylates. The tube sidewall is made of multi-layer sheet material and a covering strip is placed over the inside surface of the tube.
U.S. Pat. No. 5,649,648 issued to Lier et al. discloses a packaging system for free-flowing material such as cyanoacrylate adhesive comprising a container made of an extruded receptacle aluminum that springs back when the pressure is released and a closable applicator point fitted on its outlet aperture.
U.S. Publ. No. 2008/0167681 filed by Stenton discloses an adhesive applicator for applying medical adhesives to surgical incisions having a receiver with: a blunt, deformable cylindrical body and an adhesive-permeable foam material, a frangible ampule containing adhesive material, and a pair of wings having a pressure barb facing toward the cylindrical wall to break the frangible ampule.
U.S. Publ. No. 2008/0105580 filed by Nentwick et al. discloses an applicator tip for dispensing a cyanoacrylate-based adhesive from a reservoir having an offset opening and a distal end. The adhesive material is dispensed when pressure is applied to the applicator tip surface so that the applicator tip is in a deformed configuration.
U.S. Publ. No. 2007/0147947 filed by Stenton et al. discloses an applicator for forming layers of uniform thickness on a substrate surface by: controlling the dispensing of liquid through apertures incorporated within the applicator head, and using a supported thin layer of foam.
U.S. Publ. No. 2006/0282035 filed by Battisti et al. discloses a disposable swab applicator for containing and dispensing cyanoacrylate adhesive which is closed at one end and covered by a swab applicator at the other end. The cyanoacrylate composition is contained by a valve that can be easily opened when desired. The valve can be a ball, a bead, or a capsule. The device can also be heat sterilized using dry heat-sterilization.
All of the example applicator designs are intended for the application of a cyanoacrylate adhesive for the purpose of wound closure. To attain optimal wound closure strength, a thick, even, and consistent layer of cyanoacrylate must be formed over the laceration during application. Therefore, deploying cyanoacrylate onto a laceration is best done if the delivery applicator has a flat surface which can easily be spread across the length of the incision in one unified layer.
All of the example applicator designs are capable of laying down thick beads of adhesive to assist with wound closure. Those same applicators cannot provide the precise drops required, however, to secure a catheter within a body. In order to achieve catheter securement with reduced movement, dislodgement, and unscheduled IV restarting, the cyanoacrylate adhesive needs to be able to be applied directly to the skin at the skin-to-catheter hub interface as well as over the catheter insertion site. Indeed, the application device for the cyanoacrylate needs to be able to reach underneath the catheter hub without causing unnecessary movement to the already-inserted catheter. Due to the curative nature of cyanoacrylate, it is beneficial to be able to apply a small controlled drop or drops for enhanced drying times and overall securement.
As a result, there is a need for an applicator that can easily produce the small controlled drop or drops necessary to secure a catheter while providing optimal catheter-to-skin adhesion strength, hemostasis, and bacterial immobilization at the skin-to-catheter interface. Because the applicator will be used in the medical field, it must also be compatible with sterilization techniques.